Forms and Resources
IRB Manager
Submissions for review are made through IRBManager; click here to access the platform.
For questions related to IRBManager, email salus@salusirb.com.
Template Study Documents
Salus IRB template study documents are designed to assist in the preparation of the proposed protocol and informed consent documents. The templates include the required elements of informed consent according to 21 CFR 50.25, 45 CFR 46.116 and ICH Guidelines.
Although not required, utilizing these tools minimizes the need for extensive changes to documents, allowing for the fastest review and turnaround.
To request template study documents, contact salus@salusirb.com.
Training
Salus IRB requires that investigators and key research team members be adequately trained to meet the requirements of the federal regulations and expectations of the board. Investigators and their research teams must have a working knowledge of Good Clinical Practices (GCPs) in conducting clinical trials in human research participants.
Salus IRB provides access to training resources to ensure that investigators are prepared to fulfill their responsibilities. Such education and training may include web-based tutorials and/or verification that appropriate training was obtained prior to initiation of research.
Salus IRB’s affiliation with the Collaborative Institutional Training Initiative (CITI) allows us to offer our investigators and research team web-based training modules covering GCPs at no cost to you.
Should you choose to utilize this method of training, please follow the steps below:
- Register on the site.
- Select "Salus IRB" from the dropdown menu under "Subscriber Organizations."
- Select the "Basic Course" and the "GCP Course."
CITI will notify Salus upon your completion of the modules. CME/CEU credit documentation for this training is available through the CITI website.
- Electronic Records/Electronic Signatures 21 CFR 11
- Financial Disclosure by Clinical Investigators 21 CFR 54
- Good Clinical Practice and Clinical Trials
- Institutional Review Boards 21 CFR 56
- Investigational Device Exemption (IDE) 21 CFR 812
- Investigational New Drug (IND) 21 CFR 312
- Premarket Approval of Devices 21 CFR 814
- Protection of Human Subjects 21 CFR 50
- Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection
- Device Advice: Comprehensive Regulatory Assistance
- Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
- Investigational New Drug Applications (INDs) – Determining Whether Human Research Can Be Conducted Without an IND
- Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
- IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- Pediatrics
- Selected FDA GCP/Clinical Trial Guidance Documents
- Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
- Vaccines, Blood & Biologics: Guidance, Compliance & Regulatory Information
- Biological Materials & Data
- Certificates of Confidentiality – Privacy Protection for Research Subjects
- Federalwide Assurances (FWAs)
- HIPAA: Understanding Health Information Privacy
- Informed Consent
- Investigators
- OHRP Policy & Guidance
- Reviewing and Reporting Unanticipated Problems – Video
- Revised Common Rule Educational Materials
- Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
- Vulnerable Populations